Status:
TERMINATED
A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency
Lead Sponsor:
Pfizer
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deeme...
Detailed Description
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injecti...
Eligibility Criteria
Inclusion
- Male and female children with a minimum age of 6 years
- 2\. Prepubertal as defined by Tanner staging
- 3\. Growth hormone deficiency
Exclusion
- 1\. PGHD patients with uncontrolled pituitary tumor growth
- 2\. Tumors within 3 mm of the optic chiasm
- 3\. Serum ALT and/or AST \>= 1.5 times the upper limit of normal range
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00314938
Start Date
April 1 2006
End Date
November 1 2007
Last Update
May 16 2011
Active Locations (7)
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1
Pfizer Investigational Site
Brussels, Belgium, 1050
2
Pfizer Investigational Site
Brussels, Belgium, 1090
3
Pfizer Investigational Site
Edegem, Belgium, 2650
4
Pfizer Investigational Site
Paris, France, 75019